מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMOTRIGINE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
LAMOTRIGINE
30 Tablets
GLAXOSMITHKLINE PHARMACEUTICALS SA
Consumer Medication Information Leaflet (RiMUP) 1 LAMICTAL TABLET/DISPERSIBLE TABLET Lamotrigine (50mg, 100mg, 5mg, 25mg) What is in this leaflet 1. What LAMICTAL is used for 2. How LAMICTAL works 3. Before you use LAMICTAL 4. How to use LAMICTAL 5. While you are using it 6. Side Effects 7. Storage and Disposal of LAMICTAL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number What LAMICTAL is used for Lamictal can be used in two different conditions: Epilepsy and Bipolar disorder (maniac depression). Ask your doctor if you have any questions about why Lamictal has been prescribed for you. Your doctor may have prescribed it for another reason. How LAMICTAL works Epilepsy : Lamictal is used to treat or prevent various types of epilepsy in adults and children. Lamictal may be used on its own to treat adults and children over 12 years. Lamictal can also be used in combination with other anti- epileptic medicines in both adults and children aged 2 years and over. Sometimes other anti- epileptic medicines may be stopped after Lamictal has been started. Bipolar Disorder: Lamictal is also used to help prevent depression in adults over 18 years of age with bipolar disorder. Lamictal should not be used to treat bipolar disorder in children (under 18 years of age). Before you use LAMICTAL - When you must not use it Do not take or use Lamictal if you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of Lamictal Tablets. Lamictal is not recommended for treatment of epilepsy in children under 2 years of age. - Before you start to use it Talk to your doctor or pharmacist before taking Lamictal: If you have any kidney problems If you have ever developed a rash after taking lamotrigine orother medicines for bipolar disorder or epilepsy If you have ever developed meningitis (swelling of the membranes of the brain and spinal cord) after taking lamotrigine If you are already taking medicine that contains lamotrigine If you have int קרא את המסמך השלם
CONFIDENTIAL [GSK logo] LAMICTAL LAMOTRIGINE QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _TABLETS: _ _ _ _LAMICTAL _ 50mg Pale yellowish brown, multifaceted, superelliptical unscored tablet, branded ‘GSEE1’ on one side, with ‘50’ on the reverse. _LAMICTAL _ 100mg Pale yellowish brown, multifaceted, superelliptical unscored tablet, branded ‘GSEE5’ on one side, with ‘100’ on the reverse. _DISPERSIBLE TABLETS: _ _ _ _LAMICTAL _ 5mg White to off-white tablet with odour of blackcurrant. Elongated, biconvex unscored tablets branded 'GS CL2' on one side and '5' on the other. The tablets might be slightly mottled. _LAMICTAL _ 25mg White to off-white tablet with odour of blackcurrant. Multi-faceted, superelliptical, unscored. Branded “GSCL5” on one side and “25” on the other. The tablets might be slightly mottled. CLINICAL INFORMATION INDICATIONS EPILEPSY • ADULTS AND ADOLESCENTS _ _ _LAMICTAL _ is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome. • CHILDREN (2 TO 12 YEARS OF AGE) _ _ _LAMICTAL _ is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome (above 3 years of age only). Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended. After epileptic control has been achieved during adjunctive therapy, concomitant anti- CONFIDENTIAL epileptic drugs (AEDs) may be withdrawn and patients continued on _LAMICTAL _ monotherapy. If _LAMICTAL_ 2 mg Chewable Dispersible Tablet is not available and the calculated dose in children is less than 2.5 mg daily, then _LAMICTAL_ cannot be used. DO NOT attempt to administer partial quantities of the dispersible tablets. BIPOLAR DISORDER • ADULTS (18 YEARS OF AGE AND OVER) _ _ _LAMICTAL _ is indicated for the prevention of mo קרא את המסמך השלם